Fluorescence Imaging in Finding Tumors in Patients With Kidney Tumors
A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging of Renal Cortical Tumors
2 other identifiers
interventional
28
1 country
1
Brief Summary
RATIONALE: Using fluorescence imaging may determine the extent of kidney tumors and help in planning surgery. PURPOSE: This phase I trial is studying the best way to give indocyanine green (ICG) fluorescence imaging in finding tumors in patients with kidney tumors
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2011
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2011
CompletedFirst Posted
Study publicly available on registry
January 24, 2011
CompletedStudy Start
First participant enrolled
October 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2017
CompletedOctober 13, 2017
October 1, 2017
6 years
January 19, 2011
October 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Determination of the optimal dose of ICG which will maximize its utility in the detection of renal cortical tumors by NIR imaging technology on the da Vinci Surgical System
Compared between patients prospectively accrued to the study who had fluorescence imaging and those in the retrospective cohort whose procedures were not assisted with fluorescence imaging.
2 weeks post surgery
Secondary Outcomes (3)
Positive margin from pathology
2 weeks post-surgery
Total surgical time
At surgery
Warm ischemia time
At surgery
Study Arms (5)
Treatment 1 (fluorescence imaging and surgery)
EXPERIMENTALPatients undergo NIR fluorescence imaging with ICG and an additional 0.018 mg/kg/dose on the da Vinci Surgical System followed by standard approach robot-assisted laparoscopic partial nephrectomy.
Treatment 2 (fluorescence imaging and surgery)
EXPERIMENTALPatients undergo NIR fluorescence imaging with ICG and an additional 0.036 mg/kg/dose on the da Vinci Surgical System followed by standard approach robot-assisted laparoscopic partial nephrectomy.
Treatment 3 (fluorescence imaging and surgery)
EXPERIMENTALPatients undergo NIR fluorescence imaging with ICG and an additional 0.07 mg/kg/dose on the da Vinci Surgical System followed by standard approach robot-assisted laparoscopic partial nephrectomy.
Treatment 4 (fluorescence imaging and surgery)
EXPERIMENTALPatients undergo NIR fluorescence imaging with ICG and an additional 0.14 mg/kg/dose on the da Vinci Surgical System followed by standard approach robot-assisted laparoscopic partial nephrectomy.
Treatment 5 (fluorescence imaging and surgery)
EXPERIMENTALPatients undergo NIR fluorescence imaging with ICG and an additional 0.21 mg/kg/dose on the da Vinci Surgical System followed by standard approach robot-assisted laparoscopic partial nephrectomy.
Interventions
Undergo NIR fluorescence imaging with ICG on the da Vinci surgical system
Undergo standard approach robot-assisted laparoscopic partial nephrectomy
Given IV
Eligibility Criteria
You may qualify if:
- Patients with a computed tomography (CT) scan or magnetic resonance imaging (MRI) on preoperative assessment showing evidence of a renal cortical tumor; the renal tumor must be stage T1a/bT2
- The subject must be able to comply with the study procedures
- All subjects must have the ability to understand the risks, benefits, and alternatives of the study and the willingness to sign a written informed consent
You may not qualify if:
- Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, as total bilirubin greater than 1.5 X normal and/or serum glutamic oxaloacetic transaminase (SGOT) greater than 2 X normal
- Subject has uremia, serum creatinine greater than 2.0 mg/dl
- Subject has previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes
- Subject in whom the use of x ray dye or ICG is contraindicated including development of adverse events when previously or presently administered
- Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
- Subject is actively participating in another drug, biologic and/or device protocol
- The presence of medical conditions contraindicating general anesthesia or standard surgical approaches
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
City of Hope Medical Center
Duarte, California, 91010, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clayton Lau, MD
City of Hope Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2011
First Posted
January 24, 2011
Study Start
October 20, 2011
Primary Completion
October 9, 2017
Study Completion
October 9, 2017
Last Updated
October 13, 2017
Record last verified: 2017-10